Computer Validation Engineer Job in Sage It
Computer Validation Engineer
Sage It
4+ weeks ago
- Hyderabad, Telangana
- Not Disclosed
- Full-time
- Permanent
Job Summary
- 6+ years of experience in CSV Implementation with MES/ SCADA experience
- Ensure compliance to industry standards like GAMP5, FDA 21 CFR Part 11 on electronic records, electronic signatures etc.
- Define Risk based strategies for validation of computerized systems and author/review end-to-end Computerized Systems Validation documentation in accordance with Computerized Systems Validation Master Plan
- Perform system risk assessments, systems gap analysis, review and approve action plans to ensure compliance during and after the system validation
- Draft SOPs, writing scripts for IQ, OQ, PQ and handling CSV
- Help, guide and direct the project manager during the system implementation and validation process, and ensure compliance with corporate policies and procedures.
- Provide training related to computerized systems validation, quality and compliance to users and appropriate personnel
- Experience in Internal Audit, External Audit. Face regulatory, customer, IT Quality System related inspections for all computerized systems
- Responsible for review & verification of Corrective Action Plan for audits
- Perform periodic review/monitoring of computer systems implemented
- Proven experience in developing Master Validation Plan, validation scripts, Validation reports, all documentations required during CSV Implementation Process
Experience Required :
6 to 12 Years
Vacancy :
2 - 4 Hires
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